WO2021210821A1 - Stent pour canal cholédoque et son procédé de fabrication - Google Patents

Stent pour canal cholédoque et son procédé de fabrication Download PDF

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Publication number
WO2021210821A1
WO2021210821A1 PCT/KR2021/004125 KR2021004125W WO2021210821A1 WO 2021210821 A1 WO2021210821 A1 WO 2021210821A1 KR 2021004125 W KR2021004125 W KR 2021004125W WO 2021210821 A1 WO2021210821 A1 WO 2021210821A1
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WO
WIPO (PCT)
Prior art keywords
pin
backflow prevention
stent
pattern film
prevention pattern
Prior art date
Application number
PCT/KR2021/004125
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English (en)
Korean (ko)
Inventor
송태준
이재희
Original Assignee
재단법인 아산사회복지재단
울산대학교 산학협력단
주식회사 스텐다드싸이텍
주식회사 세운메디칼
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Filing date
Publication date
Application filed by 재단법인 아산사회복지재단, 울산대학교 산학협력단, 주식회사 스텐다드싸이텍, 주식회사 세운메디칼 filed Critical 재단법인 아산사회복지재단
Priority to JP2022537361A priority Critical patent/JP7385043B2/ja
Priority to EP21788864.3A priority patent/EP4137101A4/fr
Priority to CN202180007500.6A priority patent/CN114901220A/zh
Publication of WO2021210821A1 publication Critical patent/WO2021210821A1/fr
Priority to US17/840,626 priority patent/US20220304796A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856—Single tubular stent with a side portal passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21F—WORKING OR PROCESSING OF METAL WIRE
    • B21F45/00—Wire-working in the manufacture of other particular articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21F—WORKING OR PROCESSING OF METAL WIRE
    • B21F45/00—Wire-working in the manufacture of other particular articles
    • B21F45/008—Wire-working in the manufacture of other particular articles of medical instruments, e.g. stents, corneal rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/0105—Open ended, i.e. legs gathered only at one side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2476—Valves implantable in the body not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2002/041—Bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0008—Rounded shapes, e.g. with rounded corners elliptical or oval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A61F2240/002—Designing or making customized prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

Definitions

  • the present invention relates to a stent for bile ducts and a method for manufacturing the same, and more particularly, to a stent for bile ducts for preventing reflux of duodenal food and a method for manufacturing the same.
  • bile ducts are produced in the liver, stored in the gallbladder, and serve as a passageway for concentrated bile to flow to the duodenum. It means narrowing or blockage.
  • Korean Patent Registration No. 0170220 discloses a stent equipped with a backflow prevention means made of a resin material, a three-plate/three-plate type valve.
  • An embodiment of the present invention is a stent for bile duct that prevents backflow of food from the duodenum into the bile duct by forming a backflow prevention pattern film using a pattern member of a thread or a metal thread at the outlet of the duodenum side of the stent inserted into the bile duct, and its stent We would like to provide a production method.
  • the stent for bile duct provided with a backflow prevention means is a zigzag metal thread of a shape memory alloy on a plurality of pins respectively arranged in the circumferential direction (X) and the longitudinal direction (Y) of the columnar jig.
  • the stent for bile duct provided with a backflow prevention means is a metal of a shape memory alloy on a plurality of pins respectively arranged in the circumferential direction (X) and the longitudinal direction (Y) of the columnar jig
  • the backflow prevention pattern layer includes a cross-shaped backflow prevention pattern layer that crosses across the outlet end, a straight-shaped backflow prevention pattern layer, a zigzag shape backflow prevention pattern layer, a polygonal backflow prevention pattern layer, and a star-shaped backflow prevention pattern layer. It may be formed of any one of the prevention pattern layers.
  • the backflow prevention pattern film may be finished with a twist knot after a metal thread of one line is continuously woven from a starting point pin (P) to an ending point pin (P) via at least one pin (P).
  • the first line crossing the center of the outlet end from the first pin P1 where the metal thread of the one line is the starting point is woven into the second pin, and along the circumferential direction After being moved 90 degrees and woven into the third pin, the second line crossing the exit end from the third pin crosses the first line vertically and is woven into the fourth pin, which is the end point, and then knotted with at least one twist.
  • the backflow prevention pattern film is made by sequentially weaving the metal thread with pins (P) arranged in the circumferential direction (X) at the lower end of the jig and one vertical pin (Py) arranged in the center of the lower surface of the jig. It may be formed as a radial backflow prevention pattern film.
  • the radial backflow prevention pattern layer may be fixed to cross each other in a state in which a plurality of lines of metal threads woven through the vertical pins Py are bent.
  • the backflow prevention pattern film the lower surface of the jig forms a conical inclined outer peripheral surface
  • the metal yarns are sequentially interwoven therebetween to form a radial shape, and may be formed as a conical backflow prevention pattern film with a center protruding by the conical inclined outer circumferential surface.
  • the conical backflow prevention pattern film is a bent portion by the vertical pin (Py) is formed on the metal yarn line constituting the radial shape to form a triangular structure, and the bent portion intersects with each other in a state of interfering with each other to form a slanted structure irradiated can be achieved
  • a circular vertical fin array is formed centered on the center of the lower surface of the jig, and the vertical fins Py corresponding to the fins P arranged in the circumferential direction (X) at the lower end, respectively. ) arrays are sequentially interwoven to form a radial backflow prevention pattern film.
  • the backflow prevention pattern film has a truncated conical outer peripheral surface and a truncated conical lower surface inclined upward and downward of the jig at the lower end of the jig, and a circular vertical fin (Py) array is formed around the truncated conical lower surface in the circumferential direction with the metal thread.
  • the truncated cone-shaped backflow prevention pattern film may have a bent portion formed by the vertical pin Py on each metal thread line, and the bent portion may form an inclined structure in which each line is radiated without interfering with each other.
  • a method for manufacturing a stent for bile duct using a jig is a) shape memory in a plurality of pins respectively arranged in the circumferential direction (X) and the longitudinal direction (Y) of the cylindrical jig Forming a cylindrical body of a mesh structure by weaving the metal yarn of the alloy material in a zigzag; and b) traversing the passage exit end of the cylindrical body at least once with a pattern member of lasso or metal thread to form a backflow preventing pattern film of a network structure.
  • step b) the lower surface of the jig having a conical inclined outer circumferential surface and a vertical pin Py fixed to a central vertex, and the pins P arranged in the circumferential direction (X) at the lower end of the space between the pins P It may include the step of forming a radial pattern by sequentially weaving through a metal thread, and forming a conical backflow prevention pattern film whose center is protruded by the conical inclined outer circumferential surface.
  • the metal thread is woven from the first pin as a starting point to the central vertical pin (Py) to form a bent portion, and then extending to the third pin in the circumferential direction after being woven into the second pin; a step of moving from the third pin to the central vertical pin (Py) to form a bent part, and to extend to the fifth pin in the circumferential direction after being woven into the fourth pin; And it may include the step of forming a bent portion by woven from the fifth pin to the central vertical pin (Py), and woven with the sixth pin, which is an end point, and then knotted by twisting at least one or more times.
  • food can be prevented from flowing back into the stent (bile duct) by forming various anti-reflux pattern films using a pattern member of thread or metal thread at the outlet end of the duodenum side of the cylindrical body of the stent for bile duct. It works.
  • FIG. 1 is a conceptual diagram showing a state in which a stent for bile ducts according to an embodiment of the present invention is operated.
  • Figure 2 shows the manufacturing state of the stent for bile duct using the jig according to the first embodiment of the present invention.
  • Figure 3 is an exploded view showing the woven structure of the stent body according to the first embodiment of the present invention.
  • FIG. 4 shows an example of manufacturing a cross-shaped backflow prevention pattern film using a thread according to the first embodiment of the present invention.
  • FIG. 5 shows an example of implementation of various backflow prevention pattern films using a thread according to the first embodiment of the present invention.
  • Figure 6 shows the manufacturing state of the stent for bile ducts using a jig according to a second embodiment of the present invention.
  • FIG. 7 shows an example of implementation of various backflow prevention pattern films using metal yarns according to a second embodiment of the present invention.
  • Figure 8 shows the manufacturing state of the stent for bile ducts using a jig formed with a vertical pin according to a third embodiment of the present invention.
  • FIG. 9 shows various types of dense radial backflow prevention pattern films according to a third embodiment of the present invention.
  • Figure 10 shows the manufacturing state of the stent for bile ducts using a conical jig according to a fourth embodiment of the present invention.
  • FIG. 11 is a perspective view illustrating a conical backflow prevention pattern film according to a fourth embodiment of the present invention.
  • FIG. 12 shows an example in which the stent according to the fourth embodiment of the present invention is operated on the lesion part of the bile duct.
  • FIG. 13 is a perspective view illustrating a truncated cone-shaped backflow prevention pattern film according to a fourth embodiment of the present invention.
  • first or second may be used to describe various elements, but the elements should not be limited by the terms. The above terms are used only for the purpose of distinguishing one element from another element, for example, without departing from the scope of the present invention, a first element may be termed a second element, and similarly The second component may also be referred to as the first component.
  • FIG. 1 is a conceptual diagram showing a state in which a stent for bile ducts according to an embodiment of the present invention is operated.
  • FIG. 1 it shows a state in which the stent for bile duct 10 according to an embodiment of the present invention is inserted into the bile duct connected to the duodenum.
  • the stent for bile duct 10 is a cylindrical mesh structure manufactured using metal yarn, has its own elastic force, contracts when an external force is applied, and expands when the external force is removed.
  • the bile duct stent 10 is inserted through a stent procedure into the lesion of the lumen where the bile duct stenosis has occurred, expands the lumen with its own expansion force, and maintains the expanded lumen from narrowing again so that the bile can flow smoothly into the duodenum. plays a role
  • a pattern member such as Lasso or a metal thread is woven at the outlet end of the duodenum to be inserted into the bile duct in order to prevent backflow of food from the duodenum into the bile duct to form a backflow prevention pattern film.
  • An object of the present invention is to provide a stent for bile ducts and a method for manufacturing the same.
  • a stent including a backflow prevention pattern film using a thread and a manufacturing method thereof will be described through a first embodiment of the present invention.
  • Figure 2 shows the manufacturing state of the stent for bile duct using the jig according to the first embodiment of the present invention.
  • the bile duct stent 10 according to the first embodiment of the present invention (hereinafter, referred to as a stent for convenience) is disposed in the circumferential direction (X) and the longitudinal direction (Y) of the cylindrical jig 20 It is manufactured by weaving the metal thread 11 to the plurality of pins (P) in a zigzag manner.
  • the stent 10 may be manufactured in a standard of 8 mm to 10 mm in diameter and 5 to 7 cm in length of the cylindrical body 12, without being limited thereto, by extending the length of the jig 20 according to the size of the lesion of the patient. Custom made is possible.
  • the metal thread 11 may be made of a shape memory alloy such as nitinol so that a constant expansion force can be applied when it is at a constant temperature, such as the lumen of the bile duct, and other known stent manufacturing wires can be used.
  • a shape memory alloy such as nitinol
  • the metal yarn 11 is woven in the circumferential direction (X) in which a plurality of pins (P) are arranged with a predetermined width to form a zigzag pattern, and the zigzag pattern formed in the circumferential direction (X) intersects in a state of interference with each other. It is made of a stent 10 having a cylindrical body 12 of a mesh structure arranged at a predetermined interval (W) in the longitudinal direction (Y).
  • the cylindrical mesh structure of the stent 10 appears in a shape in which a rhombus pattern having the same length of four sides is arranged in the circumferential direction (X) and the longitudinal direction (Y) of the stent 10 .
  • Figure 3 is an exploded view showing the woven structure of the stent body according to the first embodiment of the present invention.
  • the metal yarn 11 according to the embodiment of the present invention is capable of self-contraction and expansion, has flexibility, and includes a first metal yarn 11a and a second metal yarn 11b each formed in a unit length.
  • the zigzag patterns of the first metal yarns 11a and the second metal yarns 11b are each rotated twice in a rhombus pattern intertwined with each other.
  • the checkerboard-shaped vertical intersection point represented by the dotted line is the position of the hole H into which the pin P is inserted into the jig 20, and the circular point at the intersection point is the hole H where the pin P is installed. means state. In this way, in a state in which the pin P is disposed on the jig 20, the first metal yarn 11a and the second metal yarn 11b are interwoven to produce a cylindrical body 12 having a mesh structure.
  • first metal thread 11a and the second metal thread 11b are configured to only cross without twisting in the bent state by the pin P to secure flexibility and to easily reduce the structure when loading into a catheter later. can be obtained
  • the passage of the cylindrical body 12 has a direction according to the direction in which bile flows in the bile duct, and the upper end of the passage formed on the liver or gallbladder side is defined as the inlet end (IN), and the lower end of the passage formed on the duodenum side is the outlet. It is defined as OUT.
  • the stent 10 has a network structure using a nylon thread (Lasso) 15 at the outlet end (OUT) of the duodenum to be inserted into the bile duct in the cylindrical body 12. It is characterized in that by forming the reflux prevention pattern film 13 of the duodenum food is prevented from flowing back into the bile duct.
  • Lasso nylon thread
  • FIG. 4 shows an example of manufacturing a cross-shaped backflow prevention pattern film using a thread according to the first embodiment of the present invention.
  • the cylindrical body may be manufactured to have a diameter (eg, 10 mm) of the outlet end larger than that of the central portion (eg, 8 mm), and the It shows a state in which the coating portion 14 is formed on the cylindrical body 12 .
  • the cells made of the metal yarn 11 have a shape arranged in a circle like sunflower petals around the center.
  • holes h are respectively formed in the silicon coating portion 14 of the cell formed at the outlet end of the cylindrical body 12 .
  • the backflow prevention pattern film 13 passes through any one of the holes h at the starting point and the thread 15 fixed in a zigzag to the metal yarn 11 cell formed in the circumferential direction crosses the outlet end one or more times. It may be formed in a network structure in which the process of penetrating through another hole h is repeated.
  • the thread 15 passes through the first hole h1 from the start point and then crosses the exit end of the second hole h2. ) through (S1), the metal yarn 11 formed in the circumferential direction penetrates through the third hole (h3) of the cell to interfere with each other (S2), passes through the fourth hole (h4), and then crosses the exit end After passing through the fifth hole h5 (S3) and then through the sixth hole h6 formed in the circumferential direction, it is knotted at the end point End (S4).
  • the thread 15 sequentially penetrates the hole h of the coating portion 14 formed in the cell from the starting point (Start) in one operation, and is weaved as if stitched to the cell of the metal yarn 11 and exits.
  • the cross-shaped backflow prevention pattern layer 13 After the cross-shaped backflow prevention pattern layer 13 is formed on the end, it may be knotted at the same end point as the start point (Start).
  • the backflow prevention pattern layer 13 according to the first embodiment of the present invention is not limited to the cross-shaped backflow prevention pattern layer 13 described above, and various types of backflow prevention patterns may be applied.
  • FIG. 5 shows an example of implementation of various backflow prevention pattern films using a thread according to the first embodiment of the present invention.
  • the backflow prevention pattern layer 13 can be applied with various embodiments of the backflow prevention pattern #n, such as “13#n”. 13) and the backflow prevention pattern code (#n) applied to it are marked to distinguish them.
  • the backflow prevention pattern layer 13 is not only the cross-shaped backflow prevention pattern layer 13#1 described above, but also has a thread 15 intersecting the outlet end between the hole h and the other hole h.
  • the stent 10 is manufactured to have various backflow prevention pattern films 13 according to the method of weaving to the outlet end OUT of the cylindrical body 12 using the thread 15 .
  • the stent 10 has the effect of preventing the backflow of food from the duodenum into the bile duct by forming a network structure of the regurgitation prevention pattern with the thread 15 in a state in which the stent 10 is deployed in the biliary tract and the lesion site during the procedure. have.
  • the backflow prevention pattern layer 13 may be manufactured in a manner in which the thread 15 is sewn and woven while penetrating the coating portion 14 formed around the exit end using a needle.
  • this backflow prevention pattern film 13 is made of thread, it can be easily mounted on the catheter without difficulty in reducing the diameter of the stent 10, and has a particular pattern at the same time as the deployment of the cylindrical body 12 on the lesion of the bile duct during the procedure. It has the effect of preventing the reflux of food from the duodenum into the bile duct.
  • the pattern member of the backflow prevention pattern film 13 of the stent 10 can be manufactured by using not only the thread 15 but also the metal thread 11, and a further embodiment to be described later A method of manufacturing the backflow prevention pattern film 13 using the metal yarn 11 will be described in detail.
  • Figure 6 shows the manufacturing state of the stent for bile ducts using a jig according to a second embodiment of the present invention.
  • the structure of the jig 20 and the stent 10 manufactured according to the second embodiment of the present invention is similar to the first embodiment described above, so the overlapping description will be omitted and different points will be mainly described. .
  • the stent 10 according to the second embodiment of the present invention is a backflow prevention pattern film using a metal thread 11 at the outlet end (OUT) of the duodenum side inserted into the bile duct in the cylindrical body 12. (13) is formed to prevent the reflux of food in the duodenum into the bile duct.
  • the exit end (OUT) in a state in which the cylindrical body 12 is formed by weaving the metal threads 11 through the jig 20 . It is different in that the resilient cylindrical body 12 and the backflow prevention pattern film 13 are simultaneously manufactured by forming the backflow prevention pattern film 13 using the metal yarn 11 and then heat-treating it. After that, a silicone coating jig (not shown) is inserted into the cylindrical body 12 of the stent 10 separated from the jig 20, and the coating solution is applied and then dried to complete the manufacture.
  • the backflow prevention pattern film 13 is a metal thread 11 between the pin P and the other pin P arranged in the circumferential direction (X) at one end (ie, the lower end) of the jig 20 to the outlet.
  • a cross-shaped backflow prevention pattern layer 13#1 that crosses across the end OUT may be formed.
  • the pins P1 to P12 arranged in the circumferential direction (X) at the lower end of the jig 20 are located on the same line as the exit end of the one end surface.
  • the metal thread 11 is a first line (13a) crossing the exit end from the starting point (Start) of the first pin (P1) is woven into the seventh pin (P7), and then in the circumferential direction (X)
  • the second line 13b crossing the outlet end OUT from the tenth pin P10 vertically intersects with the first line 13a, After being woven at the end point of the 4 pin P4, it is knotted with at least one twist to form a cross-shaped backflow prevention pattern layer 13#1.
  • the metal thread 11 may be twisted one or more times to the metal thread 11 constituting the exit end when woven into each pin P and fixed in a state in which they interfere with each other.
  • the metal thread 11 is continuously woven from the start point of the first pin P1 to the end point (End) of the fourth pin P4 in one line, and then is finished with a twisted knot on the other line to easily prevent backflow.
  • a pattern layer 13 may be manufactured. Furthermore, the cylindrical body 12 is first manufactured from the inlet end IN to the outlet end OUT through the jig 20 , and then the backflow is prevented at the outlet end OUT without being interrupted by the metal thread 11 . Since the pattern layer 13 can be formed, there is an advantage in that the manufacturing process can be reduced.
  • the stent 10 when the work of weaving the metal thread 11 to the backflow prevention pattern film 13 on the jig 20 is completed, the stent 10 is separated from the jig 20 and then washed and sterilized to a finished product. can be shipped At this time, the stent 10 may be shipped as a coated metal stent product after further performing a process of forming the coating portion 14 by applying a coating material to the cylindrical body 12 .
  • the coating portion 14 may be coated by applying a coating solution such as polyurethane to the cylindrical body 12 in a state in which the stent 10 is heated to a predetermined temperature.
  • the backflow prevention pattern film 13 using the metal yarn 11 according to the second embodiment of the present invention is not limited to the cross-shaped backflow prevention pattern film 13#1 described above, but various types of backflow prevention patterns. This can be applied.
  • FIG. 7 shows an example of implementation of various backflow prevention pattern films using metal threads according to the second embodiment of the present invention.
  • the backflow prevention pattern layer 13 is not limited to the cross-shaped backflow prevention pattern layer 13#1, but is formed between the fins P and the fins P.
  • the metal thread 11 is woven from the start point (Start) of the eleventh pin (P11) across the outlet end to the third pin (P3), and then sequentially across the outlet end
  • the backflow prevention pattern layer 13#3 having a zigzag shape may be formed in a way that is knotted after being woven at the end points of the ninth pin P9, the fifth pin P5, and the eleventh pin P11.
  • the start point (Start) and the end point (End) are the same.
  • the metal thread 11 is woven from the starting point (Start) of the first pin (P1) across the exit end to the ninth pin (P9), and then sequentially across the exit end After weaving at the end points of the fifth pin P5 and the first pin P1, a triangular backflow prevention pattern film may be formed in a knotted manner.
  • the polygonal backflow prevention pattern layer 13#4 may be configured not only in a triangular shape but also in various polygonal shapes, such as a square, and its starting point (Start) and ending point (End) are the same.
  • the metal thread 11 is sequentially arranged from the starting point (Start) of the first pin (P1) across the exit end of the eighth pin (P8), the third pin (P3), and the eleventh pin (P8).
  • the star-shaped backflow prevention pattern layer 13#5 may be formed in such a way that the pin P11, the sixth pin P6, and the first pin P1 are woven up to the end point (End) and then knotted.
  • the stent 10 utilizes a jig 20 to weave the metal thread 11 to the outlet end OUT of the cylindrical body 12, and various backflow prevention pattern films 13 ) can be manufactured to have
  • the stent 10 has an effect of preventing the backflow of food from the duodenum into the bile duct through the regurgitation pattern film 13 in a state in which the stent 10 is deployed in the biliary tract and the lesion site during the procedure.
  • Figure 8 shows the manufacturing state of the stent for bile ducts using a jig formed with a vertical pin according to a third embodiment of the present invention.
  • the structure of the jig 20 and the stent 10 manufactured according to the third embodiment of the present invention is similar to the second embodiment described above, so the overlapping description will be omitted and different points will be mainly described. .
  • the jig 20 includes at least one vertical pin Py formed on the lower surface 21 corresponding to the exit end OUT of the stent 10 . .
  • the stent 10 sequentially weaves between the pins (P) and the vertical pins (Py) arranged in the circumferential direction (X) at the lower end of the jig (20) with a metal thread (11), the outlet of the cylindrical body (12) It is characterized in that the radial backflow prevention pattern film (13#6) is formed at the end.
  • the metal thread 11 is woven from the start point (Start) of the twelfth pin (P12) in the clockwise direction to the vertical pin (Py) in the center and then woven to the second pin (P2) in the circumferential direction (X) is moved to the fourth pin (P4) of (S1, S2, S3), and then from the fourth pin (P4) to the central vertical pin (Py) and then to the sixth pin (P6) in the circumferential direction (X) extended to the eighth pin (P8) (S4, S5, S6), and then woven from the eighth pin (P8) to the central vertical pin (Py) and then the tenth pin (End) P10), a radial backflow prevention pattern film 13#6 is formed.
  • steps S3 and S5 for the extended movement may be omitted according to a change in a manufacturing method, and a triangular line connecting a pair of pins and a vertical pin Py may be independently formed, respectively.
  • the metal yarn 11 of the three reciprocating lines woven through the vertical pin Py may be fixed to cross each other in a bent state.
  • the backflow prevention pattern layer 13 can be manufactured with a denser density as the number of lines crossing the outlet end OUT increases.
  • a dense radial backflow prevention pattern of a modified form can be manufactured.
  • FIG. 9 shows various types of dense radial backflow prevention pattern films according to a third embodiment of the present invention.
  • the stent 10 increases the number of times it is woven into the vertical pin Py of the jig 20, and the first denser than the above-described radial backflow prevention pattern film 13#6
  • the radial backflow prevention pattern film 13#7 is shown.
  • the first radial backflow prevention pattern layer 13#7 is formed between the vertical pins Py and the pins P arranged in the circumferential direction X at the lower end of the jig 20 with the metal thread 11 . are more densely weaved sequentially to form six reciprocating lines weaved through the vertical pins Py.
  • the six reciprocating lines may be fixed in a state of being intertwined with each other.
  • a circular vertical pin Py centered on the center of the lower surface 21 of the jig 20 in a deformed form of the dense first radial non-return pattern film 13#7. ) to form an array, and through this, the second radial anti-reflux pattern film 13#8 densely formed by weaving with the metal yarn 11 is shown.
  • the metal thread 11 is a cylindrical body 12 by sequentially weaving the six pins (P) arranged in the circumferential direction (X) at the lower end of the jig (20) and the vertical pin (Py) array corresponding thereto, respectively. ), a second dense radial backflow prevention pattern film 13#8 may be formed at the outlet end.
  • the exit end of the stent 10 by utilizing at least one vertical pin (Py) formed on the lower surface 21 of the jig 20 compared to the first and second embodiments
  • the optimal conditions for a bile duct stent in consideration of clinically important physical factors are excellent flexibility, excellent radial expansile force, and the stent maintains its shape in a bent state in the bending of the bile duct and has a low axial force.
  • Conformability, minimization of the degree of shortening for placement in the lesion area, reduction of the cell size between metal threads to reduce intratumoral growth, durability, and ease of placement of the catheter as a stent delivery system must be satisfied
  • the ease of mounting the catheter means that the stent 10 is mounted on the catheter in a reduced diameter state for the procedure. This makes it difficult to insert the catheter into the bile duct, which is a disadvantage for the doctor's operation.
  • the stent for bile duct 10 has a characteristic in that the metal thread 11 crosses the exit end and a radial backflow prevention pattern film 13 of various shapes is formed, and these characteristics are It is preferable to consider the ease of mounting the catheter because it may be disadvantageous to the reduction in diameter.
  • the stent 10 for bile ducts having an improved structure for ease of mounting the catheter through the fourth embodiment of the present invention will be continued.
  • Figure 10 shows the manufacturing state of the stent for bile ducts using a conical jig according to a fourth embodiment of the present invention.
  • FIG. 11 is a perspective view illustrating a conical backflow prevention pattern film according to a fourth embodiment of the present invention.
  • the structure of the jig 20 and the stent 10 manufactured according to the fourth embodiment of the present invention is similar to the third embodiment described above, so the overlapping description is omitted, and the ease of mounting the catheter is improved The structure will be mainly explained.
  • the jig 20 forms a conical inclined outer peripheral surface 22 at the outlet end OUT of the stent 10, and at the central vertex It includes a fixed vertical pin (Py).
  • the stent 10 is formed radially by sequentially weaving between the pins (P) and the vertical pins (Py) arranged in the circumferential direction (X) at the lower end of the jig (20) using the metal thread (11). , to form a conical backflow prevention pattern film (13#9) protruding by the conical inclined outer circumferential surface (22).
  • the process of manufacturing the radial backflow prevention pattern layer 13#6 of FIG. 8 may be referred to.
  • the conical backflow prevention pattern layer 13#9 can be manufactured to have a more dense structure with improved density by increasing the number of weaving the metal yarn 11 as shown in FIG. 9(A).
  • the metal yarn 11 lines constituting the conical backflow prevention pattern film 13#9 have a bent portion 11c formed by a vertical pin Py to form a triangular structure, and the bent portion 11c is They intersect each other in a state of interference to form a radiated gradient structure.
  • FIG. 12 shows an example in which the stent according to the fourth embodiment of the present invention is operated on the lesion part of the bile duct.
  • the stent 10 according to an embodiment of the present invention is mounted on the catheter in a reduced diameter state and moved past the lesion in the bile duct.
  • the conical backflow prevention pattern film (13#9) is mounted on the inner diameter of the catheter for stent operation, the cylindrical body 12 is reduced by external pressure and at the same time the bent portion 11c is folded without any physical resistance. It has the effect of facilitating catheter mountability.
  • the stent 10 exposed while the catheter is retracted is expanded to show a state in which the lesion in the bile duct is expanded.
  • the conical reflux prevention pattern film 13#9 extends to the duodenal passage of the bile duct to prevent food from flowing back into the bile duct, and discharges bile flowing in the bile duct into the duodenum.
  • FIG. 13 is a perspective view showing a truncated cone-shaped backflow prevention pattern film according to a fourth embodiment of the present invention.
  • the jig 20 is a truncated conical outer peripheral surface 23a and a truncated conical lower surface 23b inclined toward the upper and lower conical structures of the truncated cone structure at the exit end OUT of the stent 10. and a circular vertical fin (Py) array formed around the center of the truncated conical lower surface 23b.
  • the stent 10 is a vertical pin arranged in a circular shape on the lower surface of the truncated cone 23b corresponding to the pins (P) arranged in the circumferential direction (X) at the lower end of the jig (20) with the metal thread (11). (Py) It is possible to weave the array sequentially to form a frustoconical backflow prevention pattern film 13#10 at the outlet end of the cylindrical body 12 .
  • a bent portion 11c is formed by a vertical pin Py on each of the metal yarn lines 11 forming the frustoconical backflow prevention pattern film 13#10, and the bent portion 11c interferes with each other. It is possible to achieve a radiated inclined structure without
  • food is prevented from flowing back into the stent (bile duct) by forming various backflow prevention pattern films using a pattern member of thread or metal thread at the outlet end of the duodenum side of the cylindrical body of the stent for bile ducts.
  • a pattern member of thread or metal thread at the outlet end of the duodenum side of the cylindrical body of the stent for bile ducts.
  • the embodiment of the present invention is not implemented only through the apparatus and/or method described above, and may be implemented through a program for realizing a function corresponding to the configuration of the embodiment of the present invention, a recording medium in which the program is recorded, etc. Also, such an implementation can be easily implemented by an expert in the technical field to which the present invention pertains from the description of the above-described embodiment.

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Abstract

Sont divulgués un stent pour canal cholédoque et son procédé de fabrication. Un stent pour canal cholédoque comprenant un moyen de prévention de reflux selon un mode de réalisation de la présente invention comprend : un corps cylindrique ayant une structure maillée fabriquée par tissage en zigzag de fils métalliques constitués d'un alliage à mémoire de forme sur une pluralité de broches disposées respectivement dans la direction circonférentielle (X) et la direction longitudinale (Y) d'un gabarit cylindrique ; une partie film revêtue sur une cellule de fils métalliques ayant la structure maillée ; et un film à motif de prévention de reflux dans lequel chacun des trous est formé dans la partie film de la cellule formée au niveau de l'extrémité de sortie du corps cylindrique et un lasso, qui passe par l'un des trous (h) et est tissé en zigzag et fixé à la cellule de fils métalliques orientée dans la direction circonférentielle, croise l'extrémité de sortie au moins une fois pour former une structure de réseau.
PCT/KR2021/004125 2020-04-17 2021-04-02 Stent pour canal cholédoque et son procédé de fabrication WO2021210821A1 (fr)

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JP2022537361A JP7385043B2 (ja) 2020-04-17 2021-04-02 胆管用ステントおよびその製作方法
EP21788864.3A EP4137101A4 (fr) 2020-04-17 2021-04-02 Stent pour canal cholédoque et son procédé de fabrication
CN202180007500.6A CN114901220A (zh) 2020-04-17 2021-04-02 胆管支架及其制作方法
US17/840,626 US20220304796A1 (en) 2020-04-17 2022-06-15 Bile duct stent and method of manufacturing the same

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KR10-2020-0046815 2020-04-17
KR1020200046815A KR102409245B1 (ko) 2020-04-17 2020-04-17 담관용 스텐트 및 그 제작 방법

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CN115553972B (zh) * 2022-10-19 2023-10-20 常州乐奥医疗科技股份有限公司 一种胆道支架制造方法及胆道支架
CN116350411A (zh) * 2023-04-11 2023-06-30 江苏唯德康医疗科技有限公司 一种支架编织方法及使用该方法编织的支架

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US20080223476A1 (en) * 2001-10-09 2008-09-18 Boston Scientific Scimed, Inc. Medical stent with a valve and related methods of manufacturing
KR20040021266A (ko) * 2002-09-03 2004-03-10 주식회사 엠아이텍 스텐트 및 이 스텐트의 제조방법
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CN114901220A (zh) 2022-08-12
JP2023508863A (ja) 2023-03-06
KR102409245B1 (ko) 2022-06-15
JP7385043B2 (ja) 2023-11-21
EP4137101A1 (fr) 2023-02-22
KR20210128756A (ko) 2021-10-27
EP4137101A4 (fr) 2023-09-13
US20220304796A1 (en) 2022-09-29

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